Screening for earlY Heart Failure Diagnosis and Management in Primary Care or at HOme Using Natriuretic Peptides and echocardiographY "SYMPHONY-HF"

NCT05919342 | Recruiting DMC FDA Device

• 1 other identifier: 1
• Study Type: interventional
• Target: 3,904
• Locations: 5 countries
• Sites: 7

Brief Summary

This is an international prospective, multicentre, unblinded, randomised-controlled trial. The primary aim is to assess a targeted screening strategy to detect undiagnosed heart failure in high-risk patients.

Conditions

Heart Failure; Cardiovascular Diseases

Keywords

Screening; Biomarker; NT-proBNP; Echocardiography; Community; Registry

Outcome Measures

Primary Outcomes (1)

• Diagnosis of heart failure within 6 months

  6 months

Secondary Outcomes (2)

• Diagnosis of HFrEF within 6 months

  6 months

• People diagnosed with HFrEF receiving GDMT within 6 months

  6 months

Other Outcomes (15)

• Diagnosis of HFmrEF within 6 months

  6 months

• Diagnosis of HFpEF within 6 months

  6 months

• People diagnosed with HFmrEF and HFpEF receiving SGLT2i therapy within 6 months

  6 months

Study Arms (2)

Routine care arm

NO INTERVENTION

Patients in this arm will undergo routine care. They will be managed and followed up as per routine clinical care. They will be remotely monitored for HF events by follow up through electronic records and routinely collected data.

Investigational arm

EXPERIMENTAL

Patients in this arm will have a blood sample performed for measurement of N-terminal prohormone of B-type natriuretic peptide (NT-proBNP). Patients with an elevated Roche NT-proBNP (≥125 pg/mL) will undergo a transthoracic echocardiogram, clinical examination for signs of HF, HF symptom assessment, an ECG). Patients will undergo echocardiography with a CE-marked, FDA-approved handheld point of care (POC) EchoNous echocardiogram device in all countries. The US2.ai algorithm (which is also CE-marked and FDA-approved) will generate an AI-automated echocardiogram report.

Diagnostic Test: NT-proBNP

Interventions

NT-proBNP DIAGNOSTIC_TEST

Patients will undergo an NT-proBNP which will guide their future involvement within the study. Patients with an NT-proBNP of ≥125 pg/mL will undergo transthoracic echocardiogram along with a clinical assessment - any diagnosis of HF will result in patients undergoing referral for initiation of guideline directed medical therapy (for HF).

Investigational arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥40 years of age
• Informed consent
• Two or more of the following risk factors for heart failure:
• Coronary artery disease (either a previous documented type 1 myocardial infarction or coronary artery bypass grafting or percutaneous coronary intervention or documented stenosis of an epicardial coronary artery \[50% left main stem or \>70% left anterior descending, circumflex or right coronary artery\])
• An established diagnosis of diabetes (type 1 or type 2)
• Persistent or permanent atrial fibrillation (not paroxysmal atrial fibrillation)
• Previous ischemic or embolic stroke
• Peripheral arterial disease (previous surgical or percutaneous revascularisation or a documented stenosis greater than 50% of a major peripheral arterial vessel).
• Chronic kidney disease (defined as an estimated glomerular filtration rate \<60mL/min/1.73m2 or eGFR 60-90mL/min/1.73m2 and UACR \>300mg/g).
• Regular loop diuretic use (any dose at any dosing interval) for \>30 days.
• COPD (evidenced by one of the following: PFTs showing airway obstruction, diagnosis by respiratory physician, CT scan reporting presence of emphysema or treatment with national guideline advocated COPD therapy).

You may not qualify if:

• Inability to give informed consent e.g., due to significant cognitive impairment
• Previous documented diagnosis of heart failure
• Current renal replacement therapy
• Anyone who, in the investigators' opinion, is not suitable to participate in the trial for other reasons e.g., a diagnosis which may compromise survival over the study period

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator
• National Heart Centre Singapore: collaborator
• Karolinska University Hospital: collaborator
• Uppsala University: collaborator
• Montreal Heart Institute: collaborator
• Rigshospitalet, Denmark: collaborator
• University of British Columbia: collaborator
• The Cleveland Clinic: collaborator
• Université de Montréal: collaborator
• AstraZeneca: collaborator
• Roche Pharma AG: collaborator
• Us2.ai: collaborator

Study Sites (7)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

University of British Columbia

Vancouver, British Columbia, Canada

NOT YET RECRUITING

University of Montreal

Montreal, Quebec, Canada

NOT YET RECRUITING

Rigshospitalet, Copenhagen University Hospital

Copenhagen, Denmark

NOT YET RECRUITING

Karolinska University Hospital

Stockholm, Sweden

NOT YET RECRUITING

Uppsala University

Uppsala, Sweden

NOT YET RECRUITING

University of Glasgow

Glasgow, Scotland, G12 8TD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Failure; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

• Mark C Petrie, MbChB

  University of Glasgow

  PRINCIPAL INVESTIGATOR

• Carolyn SP Lam

  Duke-NUS Graduate Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark C Petrie, MbChB

CONTACT

+44(0) 141 330 2677; mark.petrie@glasgow.ac.uk

Kieran F Docherty, MbChB

CONTACT

+44(0) 141 330 2677; kieran.docherty@glasgow.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After agreeing to consent, patients will be randomised 1:1 to one of two arms; a "Routine care arm" in which patients will undergo routine care or a 2. "Investigational arm" - patients in this arm will have a blood sample performed for measurement of N-terminal prohormone of B-type natriuretic peptide (NT-proBNP). Patients with an elevated Roche NT-proBNP (≥125 pg/mL) will undergo a transthoracic echocardiogram, clinical examination for signs of HF, HF symptom assessment, an ECG). Patients will undergo echocardiography with a CE-marked, FDA-approved handheld point of care (POC) EchoNous echocardiogram device in all countries. The US2.ai algorithm (which is also CE-marked and FDA-approved) will generate an AI-automated echocardiogram report. In Scotland all patients will also undergo a conventional echocardiogram. Patients who are classified as having heart failure (HFrEF, HFmrEF and HFpEF) will be referred for appropriate follow up.

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: June 26, 2023
• Study Start: December 22, 2022
• Primary Completion: June 21, 2024
• Study Completion (Estimated): December 21, 2032
• Last Updated: August 4, 2023

Record last verified: 2023-08

Locations

CA (2); SE (2); US (1); DK (1); GB (1)